The use of feeding tubes which provide nutritional formula directly into the stomach of patients who are incapable of swallowing for one reason or another have been well known for years. Many different types have been devised which are commonly inserted into the patient by way of surgery, radiological placement or more recently, percutaneous endoscopic gastrostomy. In some cases an opening is cut into the skin, fascia and stomach wall and the gastrostomy tube is directly placed therein. This required the employment of general anesthesia which added an additional risk factor to the patient's well being.
In percutaneous endoscopic gastrostomy, the general procedure comprises inserting an endoscope into the stomach by way of a patient's mouth and esophagus. The stomach is then inflated and a needle and cannula are inserted through an appropriate site from the skin surface into the stomach wall. A snare is fed into the stomach through the endoscope and is looped about the cannula. A guidewire is fed into the stomach through the cannula and is pulled up through the esophagus and mouth by the snare and endoscope. A gastrostomy catheter is then attached to the guidewire and is pulled down through the mouth, through the esophagus to the stomach by pulling the end of the guidewire that protrudes from the cannula which maintains a small hole made in the stomach with the needle. The catheter is pulled though the hole as well, its passage assisted by means of a tapered dilator at the leading end. The catheter is then held in place by means of a retention means or bolster guard which generally consists of a larger, planar surface area than the catheter and lies flat against the interior of the abdominal wall.
Suitable retention means currently in existence include a radially extending flange element, a collar, cuff or a balloon. Another retention means may be placed externally against the skin where the tube exits the skin in order to better secure the catheter in place. The tube may then be connected to an enteral feeding delivery system and the nutritional formula delivered. Accordingly, a number of variations to this general procedure are described in U.S. Pat. No. 5,080,650 to Hirsch et. al., U.S. Pat. No. 4,900,306 to Quinn et. al. and U.S. Pat. No. 4,861,334 to Nawaz.
The gastrostomy tube generally must be removed at some point either due to the conclusion of the need for gastronomic feeding or if the device needs to be replaced for one reason or another. Obviously, the existence and securement of the retention means to the skin surface and stomach wall prevents any easy external removal thereof without potentially causing damage to the stomach, abdominal fascia and skin. Various techniques have been employed to facilitate the removal procedure. These include cutting the gastrostomy tube at the skin level and retrieving the internally disposed portions endoscopically; cutting the gastrostomy tube at the skin level and allowing the retention means and internal portion of the tube to be expelled by means of excretion through the gastrointestinal tract, and surgically removing the entire tube through the creation of a larger incision.
All these procedures have inherently associated problems. The endoscopic retrieval process places the patient at risk as esophageal tissue damage and blockage of the trachea may result during retraction of the tube and retention collar or flange. The method whereby the system is excreted by way of the gastrointestinal tract runs the risk of intestinal or bowel blockage. Surgical removal always runs the risk of patient trauma, anesthesia overdose and excessive bleeding.
A number of attempts have been made in the art in an effort to make insertion and removal of the gastrostomy tube a more simple, less invasive procedure. U.S. Pat. No. 5,073,166 to Parks et. al. discloses a method and apparatus for the emplacement and removal of a gastrostomy catheter that has retention means consisting of an expandable locking mechanism and a locking ring. The locking mechanism comprises expandable legs or arms that are retracted during insertion of the tube into the body so as to afford the smallest diameter with least resistance. An insertion tool is then used to expand the legs, clamping the tube to the patients skin and stomach. The tube may be removed by again inserting the tool at the appropriate time, contracting the legs about the cylindrical body of the tube so that it is "unlocked" and pulled out and withdrawn from the body.
U.S. Pat. No. 5,356,391 to Stewart discloses and claims a gastrostomy tube with a flexible, internal retention flange comprising a collapsible dome shape which reduces patient trauma and risk during tube insertion and removal. The shape of the dome enables it to conform to the contour of the patients stomach and yet readily collapses when longitudinal pressure is applied through retraction of the tube thereby reducing the diameter of the dome for least resistance.
U.S. Pat. No. 5,112,310 to Grobe discloses a percutaneous endoscopic gastrostomy tube in which the retention means is expandable and integral with the tube and may comprise an inflatable balloon or an expandable and retractable basket for securing the tube to the gastric wall. The balloon may be inflated with air or water after insertion and expands to secure the tube to the wall between it and a collar. The balloon can be deflated thereby reducing its size for retraction and removal of the tube. The basket type retention means consists of a plurality of circumferentially spaced ribs which are attached at one end to the distal end of the tube and at the other end to a slidable collar. When retracted, the diameter of the tube is reduced and the tube may be pressed through an ostomy incision. Expanding the basket clamps the collar against the stomach wall thereby holding the tube in place. The ribs are then retracted once the tube is to be removed.
U.S. Pat. No. 5,074,846 to Clegg et. al. and U.S. Pat. No. 4,795,430 to Quinn et. al. both disclose percutaneous endoscopic ostomy devices in which the tube is percutaneously secured to the liner of the stomach using a balloon or an inflatable cuff, respectively. Deflated, both can be passed into the lumen through a small opening in the stoma created by an ostomy. Inflated, they expand and maximizing the circumference of the tube they press against the stomach wall thereby securing the tube to the body. Once the patient no longer is in need of enteral feeding or tube replacement is required the balloon or cuff may be deflated to minimize the circumference of the tube for easier withdrawal.
None of the prior art retention means provide a universal method for the simple extraction and removal of a wide variety of tubes. Moreover, all of the aforementioned references comprise fairly complex structures which are an integral part of the tube itself and cannot afford the surgeon or enterologist the minimal tubular diameter for least friction and resistance against the stomach wall and fascia upon removal. The integral and complex nature of these structures can lead to inoperative or faulty devices when used which may ultimately prevent the simple retraction of the tube. Balloons may not deflate, baskets may fail to collapse, and collars or domes may become obstructed and fail to fold in. Although seemingly minor, such breakdowns can create major problems when the patient is at risk.
It is an object of the present invention to provide a simple means for the percutaneous extraction or withdrawal of an enteral feeding tube from its secured position within the stomach wall. More specifically, it is an object of the present invention to provide a retention means extractor that is easily inserted in the stoma without causing tissue trauma wherein it readily collapses and captures a wide variety of collar or flange style bolster retention means which are then readily pulled out of the stoma without further damage or tear to the stomach, muscle or skin tissue.